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Oropharynx CancerPhase 3ARTIXNCT01874587

Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

A Phase 3 study testing adaptative radiotherapy in people with Oropharynx Cancer, run by Center Eugene Marquis at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Oropharynx Cancer
What is being tested?
adaptative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
11 sitesFrance
Study dates
Jul 2013to 8 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
  • Age ≥ 18 years and ≤ 75 years
  • Performance status (WHO ≤ 2)
  • Renal, hepatic and cardiovascular functions allowing systemic treatment administration
  • Adapted stomatologic care
  • Signed informed consent form
  • Membership or beneficiary of a national insurance scheme

Who cannot join

  • Both parotids totally included in the target volume
  • Stages T1 or T2 with positive node disease N1
  • Neoadjuvant chemotherapy
  • Exereses of primitive tumor and/or nodes
  • History of other cancer within 5 years (except for basocellular epithelioma and cervical)
  • Previous neck radiotherapy
Show all 14Show fewer
  • Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
  • Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
  • Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
  • Patient already recruited in another biomedical research ( non interventional study is authorized)
  • Pregnant or breast feeding patients
  • Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
  • Patient is deemed incapable of giving informed consent
  • Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Clinique Claude Bernard

    Albi

  • Clinique Pasteur - Saint Esprit

    Brest, 29200

  • CRLCC Baclesse

    Caen, 14076

  • CRLCC Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon

  • CRLCC Antoine Lacassagne

    Nice, 06189

  • CHU de la Milétrie

    Poitiers, 86000

  • Centre Eugene Marquis

    Rennes, 35042

  • CRLCC Henri Becquerel

    Rouen

  • Centre Paul Strauss

    Strasbourg

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

Official title: Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia

The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

Being tested
adaptative radiotherapy
Keywords
Adaptative radiotherapy, oropharynx carcinoma, xerostomia
Medical subject headings
Oropharyngeal Neoplasms, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adaptative radiotherapyRadiation

    weekly replanning

Study groups in NCT01874587
Study groupRoleWhat they receive
standard radiotherapyNo interventionsingle pre-treatment planning before radiotherapy
adaptative radiotherapyExperimentaladaptive Radiotherapy based on a weekly replanning
Receives: Radiation: adaptative radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary flow measure

    The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.

    Measured: 12 months after the end of radiotherapy

Secondary outcomes (6)

  1. Xerostomia

    salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy

    Measured: From before treatment to 24 months after the end of radiotherapy

  2. Salivary flow

    measured by scintigraphy

    Measured: Before treatment and 12 months after the end of radiotherapy

  3. Local control

    analysed according stages T and N, HPV status

    Measured: 2 years

  4. Early and late toxicities

    early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy

    Measured: From beginning of the radiotherapy up to 2 years after the end of radiotherapy

  5. Survival

    overall and disease free survival

    Measured: 2 years

  6. Head and Neck functionality

    MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy

    Measured: Before treatment to 24 months after the end of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion10 Dec 2019
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874587
Sponsor's protocol ID
2012-RdC-ORL-Th
Other IDs
2012-A00426-37
Acronym
ARTIX
Status last verified
Jul 2021
First submitted
25 Apr 2013
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Castelli J, Thariat J, Benezery K, Hasbini A, Gery B, Berger A, Liem X, Guihard S, Chapet S, Thureau S, Auberdiac P, Pommier P, Ruffier A, Perrier L, Devillers A, Campillo-Gimenez B, de Crevoisier R. Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Aug 1;9(8):1056-1064. doi: 10.1001/jamaoncol.2023.1352.

    PubMed 37261806

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adaptative radiotherapy in people with Oropharynx Cancer, run by Center Eugene Marquis at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary flow measure (time frame: 12 months after the end of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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